“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era.  To be very brief, Jurisfiction is the fictional police force for BookWorld, one of Fforde’s fictional universes.  Tuesday is a Jurisfiction agent (sometimes rather more than that).

“Jurisfiction,” unfortunately, is also something we see in our line of work, sometimes making us wonder whether the likes of Emperor Zhark, the Red Queen, and Pinky Perkins may have aliases who serve in the all-too-real judicial branches here in the States.  Jurisfiction is shorthand for a decision that gets a legal issue totally bollixed  – perhaps applying the UltraWord to the issue – allowing the user to control the plot, garbling it, and ultimately making all precedent useless.

We recently ran across a shining example of jurisfiction in the discussion of FDA warning letters found in Mihok v. Medtronic, Inc., ___ F. Supp.3d ___, 2015 WL 4722847 (D. Conn. Aug. 10, 2015).  Here’s what Mihok held on that subject:

The Complaint is rooted in FDA Warning Letters which state that [defendant] failed to comply with the CGMP regulations. . . .  While perhaps not dispositive on the issue, the FDA’s conclusions and interpretations of its own regulations are likely to receive a considerable degree of deference.  See, e.g., Conroy v. Dannon Co., Inc., No. 12 CV 6901(VB), 2013 WL 4799164, at *6 (S.D.N.Y. May 9, 2013) (stating that the FDA’s interpretations of its own regulations promulgated under title 21 “are ‘controlling unless plainly erroneous or inconsistent with the regulations’ or there is any other reason to doubt that they reflect the FDA’s fair and considered judgment”) (citing and quoting PLIVA, Inc. v. Mensing, ––– U.S. ––––, ––––, 131 S.Ct. 2567, 2575, 180 L.Ed.2d 580 (2011)); Dorsey v. Housing Auth. of Baltimore City, 984 F.2d 622, 632 (4th Cir. 1993) (finding district court abused its discretion in refusing to consider regulatory agency’s assessment of defendant’s compliance with agency regulations and noting that the district “court should welcome [the agency’s] appraisal of [the defendant’s] compliance with regulations, given its concern for deference to agency interpretations of its own regulations”). Indeed, it is precisely when a court is called upon to interpret the regulations, i.e., when they are ambiguous, and where their application to facts raises complex issues, that the court is most likely to defer to the FDA’s prior determinations.  See Wilson v. Frito-Lay N. Am., Inc., 961 F. Supp.2d 1134, 1142 (N.D. Cal. 2013) (noting that “an agency’s informal interpretation of its own ambiguous regulation is [typically] controlling” but declining to give “deference to two warning letters that the FDA sent” because neither party to the case “contended that the FDA regulations . . . [w]ere ambiguous, and the Court d[id] not find that they [we]re”); James T. O’Reilly, et al., 1 Food & Drug Admin. §4:56 (4th Ed. 2015) (“The FDA is allowed great deference in the interpretations of its own regulations…. The more complex the issue, the more scope is likely to be given for the FDA to draw the interpretations.”).

As to deference, Defendants cite a non-binding case, Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939 (E.D. Wisc. 2008), for the proposition that “a warning letter from the FDA is not considered a final agency action,” and contend that, as a result, “Plaintiffs’ allegations … raise legal questions as to the potential effects of various actions by a federal agency … [which] should be decided in a federal forum.”  The Second Circuit has not taken a position on whether an FDA Warning Letter is considered a final agency action.  Even if it is not, such letters may still be entitled to deference.  See Cmty. Health Ctr. v. Wilson-Coker, 311 F.3d 132, 138 (2d Cir. 2002) (“[E]ven relatively informal [agency] interpretations, such as letters from regional administrators, warrant respectful consideration” where the statute at issue is complex and the regulatory agency possesses “considerable expertise”) (citations and quotations omitted).  Regardless, they may serve as evidence of regulatory violations.  Gelber v. Stryker Corp., 788 F. Supp.2d 145, 155–56 (S.D.N.Y. 2011) (finding plaintiffs who provided FDA Warning Letters as evidence of violations of FDA regulations stated claims for manufacturing defects).

Mihok, 2015 WL 4722847, at *5-6 (citations not omitted, for once).  Under this analysis, there being no undecided FDA-related issue, Mihok was remanded to state court.

Continue Reading Warning Letters and Jurisfiction

We have had some time now to ruminate over the South Carolina Supreme Court’s opinion in State of South Carolina ex rel. Wilson v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2012-206987, 2015 WL 775094 (S.C. Feb. 25, 2014).  In Wilson, the state attorney general brought an enforcement action against the manufacturer of the atypical antipsychotic Risperdal under the state’s Unfair Trade Practices Act (having the dysphonius acronym “SCUTPA” in the opinion) and recovered $327 million in civil penalties. Although the Supreme Court reduced the award to $136 million, it mainly affirmed a verdict that, in our view, has multiple problems.  What problems?  Well, how about a nine-figure civil penalty for “deceptive” conduct when the state neither alleged nor proved that a single person was deceived or that the conduct had any adverse impact on anyone?  We call that a problem, but we’ll get back to that particular point in a moment.

Those who read our 2014 Ten Best column and those who dialed into our teleseminar in January on those cases know a little about Risperdal and the various states’ lawsuits against the drug’s manufacturer.  What happened was that the FDA asked all manufacturers of atypical antipsychotics to review data on diabetes, which resulted in a new warning on diabetes being added to the labels.  The FDA also required a Dear Healthcare Provider Letter, which the manufacturer of Risperdal sent, but the letter included information that was technically off label.

That resulted in an FDA warning letter in April 2004 stating that the DHCP Letter was “false or misleading” in violation of the FDCA, which in turn resulted in the manufacturer sending a corrective DHCP Letter.  Wilson, 2015 WL 775094, at **5-6.  That seems to be when various state attorneys general and their contingent-fee lawyers took interest.  Two of our Ten Best cases of 2014 were state false claims act cases arising out of these events where the states of Louisiana and Arkansas recovered very large judgments against this manufacturer.  Both verdicts were reversed on appeal, which was good news.

Continue Reading An Atypical View of Causation and Harm from South Carolina

The MDL court in West Virginia in the pelvic mesh litigation is continuing to issue pre-trial opinions.  Amongst those issued last week was an opinion addressing 24 motions in limine filed by plaintiffs and defendant, Boston Scientific Corporation (“BSC”).  Eghnayem v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 153284 (S.D.W. Va. Oct. 28, 2014).  We won’t address all the court’s rulings.  A number of them, as is almost always the case, were denied without prejudice to re-raising them at trial.  But some are either interesting or address issues frequently raised in mass tort trials.  So we discuss them here.

Exclusion of Material Safety Data Sheets (“MSDS”).  Admissibility of MSDS is often an issue in drug and device law litigation.  BSC sought to exclude the MSDS for polyethylene because it was not used in BSC’s mesh product.  They won – for obvious reasons.  The loophole that plaintiffs apparently tried to exploit was that certain BSC employees answered questions at their depositions about the polyethylene MSDS, incorrectly believing that it was the MSDS for a different substance – polypropylene – that is contained in BSC’s mesh product.  The court figured that out and excluded the polyethylene MSDS.

BSC also tried to exclude the MSDS for polypropylene, a material that is in its product.  No luck. BSC argued that a representative from the chemical company that made the polypropylene testified that the MSDS cautionary language was not placed there for scientific concerns.  The court found that testimony to be unclear and that the witness had actually testified that he didn’t know who drafted the MSDS or why it was written.  The court denied BSC’s motion, so BSC went one for two on its attempts to exclude the MSDS.  Id. at *5-8.

Continue Reading The West Virginia Pelvic Mesh Court Issues in Limine Rulings

The MDL court in the pelvic mesh litigation issued in limine rulings for an upcoming trial involving Ethicon’s TVT Secur system.  In re Ethicon, Inc., 2014 U.S. Dist. LEXIS 14088 (S.D.W Va.  Feb. 5, 2014).  There were almost 30 rulings.  The motions addressed topics that ranged from the mundane, such as clinical trials and

(This post is from the Cozen side of the blog only.)

Whenever you remove a complaint that is an obvious case of fraudulent joinder, you think to yourself, “Why don’t they just admit it?”  “They” being the plaintiffs’ lawyers, and the admission being that they joined the hometown doctor or pharmacy or sales rep solely 

If somebody were to ask us whether as a general proposition it’s relevant to the presentation of a product liability case about a prescription medical product that the FDA had approved/cleared the product and the defendant had complied with FDA regulations, our immediate reaction would be “Duh, of course, it’s relevant.”  We may have an overriding preemption or standing argument under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but relevance?  Particular aspects of FDA approval or compliance might not pertain to the particular defect allegations in a given case, but in general, the relevance of the fact the FDA has allowed the product on the market, and that the manufacturer complied with pertinent FDA regulations, seems unassailable.

Ask that to the other side, however, and the answer will be “only if it helps me win.”  Plaintiffs are more than happy to offer evidence of FDA approval/compliance evidence – but only if it’s about non-approval/noncompliance.  If the FDA pedigree of a particular product doesn’t include any sort of FDCA violation, then the same counsel who so zealously advocated the relevance of the FDA last week is quite happy the next week to disavow every word of it.  That happened to us recently, hence this post.

When an application is required to sell an FDA-regulated product (including almost all such products likely to be involved in litigation), the manufacturer cannot sell it in the U.S. until and unless the FDA says ‘yes.’  Indeed, over a dozen states have statutes that, to one extent or another, presume that products passing FDA muster aren’t defective.  For reasons such as these, the overwhelming majority of the caselaw recognizes the relevance of the FDA’s decisions.

Putting aside preemption (which is predicated on federal, not state, legal principles) the general state-law rule is that a product’s compliance with FDA regulations – whether they’re characterized as “minimum” or otherwise, is relevant, albeit not controlling, in product liability litigation.

[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.

Restatement (Third) of Torts, Products Liability §4(b) (1998).  The supporting Reporters’ Note to §4(b) confirms:

The overwhelming majority of jurisdictions hold that compliance with product safety regulation is relevant and admissible on the question of defectiveness, but is not necessarily controlling.

Continue Reading FDA Device Clearance – Clearly Relevant

The recent magistrate’s decision in Fecho v. Eli Lilly & Co., 2012 WL 6681895 (Mag. D. Mass. Dec. 21, 2012) (“Fecho II”), isn’t good, but it could have been far worse.  While the decision stretches prescription drug warning causation to the breaking point, at least it didn’t do what the plaintiffs sought, which was the wholesale importation of asbestos-style tactics of proving causation into drug litigation.  Still, to escape summary judgment required unprecedented application of both the Federal Rules of Evidence and Pennsylvania law (although not the law ordinarily applied in product liability cases).

Here’s what went on.  Fecho is a testament to old litigation not dying, but spreading to different injury allegations.  Fecho involves DES.  That’s right old-fashioned diethylstilbestrol – prohibited from use in pregnant women by the FDA since 1971.  As everyone in our line of work knows, DES is linked to a rare type of cancer in young women exposed in utero – a cancer that developed around the time of puberty.

That development, of course, brought about a wave of litigation over events that happened – due to the delay in cancer development – between one and three decades earlier.  Because DES was never patented, many DES plaintiffs could not determine who made the drug they were exposed to.  That proof problem led pro-plaintiff courts in the 1980s to invent “market share liability,” which all in all was probably the radical and ill-conceived expansion of tort liability of our legal lifetimes.  Fortunately, most states didn’t adopt it.

But time passes, and with the youngest of the so-called “DES daughters” now over 40, one would expect the statute of limitations finally to put this litigation to bed – NOT!

Rather than finding something else to sue over, plaintiffs (some of them, anyway) are now claiming that the same in utero exposure to DES causes breast cancer.  Unlike the DES litigation of the 1980s and 1990s, the medical causation science for this new theory isn’t very good, being limited to a couple of studies that plaintiffs’ experts have to massage thoroughly in order to discover any statistically significant increase in any “cohort.”  See Fecho v. Eli
Lilly & Co.
, 2012 WL 194419, at *2 (Mag. D. Mass. Jan. 20, 2012) (expert found statistical significance in one “subset” of first study that “could be characterized as too thin” only after “control[ing] for” unspecified “confounding factors”); id. (second study had an even “smaller hazard ratio,” so the expert “discounted an excess risk calculation in preference for a proportionate hazards model”) (“Fecho I”).  Not only that, but there’s no distinction between purported DES breast cancer and any other breast cancer.  Id. (“temporal relationship between the exposure and the development of the disease . . . tracks the natural age at which breast cancer typically appears”).  In short, DES breast cancer litigation not only has all the causation problems of earlier DES litigation, but junk medical causation science has replaced the prior “signature disease.”

Continue Reading Asbestos Causation Tactics And Pharmaceutical Litigation

We’ve been reading the Keith Richards autobiography, Life, and it made us think about the past. The Rolling Stones were formed 50 years ago, in April 1962. We were Beatles fans in the 1960’s. (Still are). When the Rolling Stones showed up on The Ed Sullivan Show they seemed sort of terrifying. (Still are.)

Motions in limine were decided (or not) recently in Wolfe v. McNeil-PPC, Inc., 2012 U.S. Dist. Lexis 2160 (E.D. Pa. Jan. 9, 2012).  The defendant did pretty well, so here’s a brief listing of the highlights (this isn’t everything, as some were case specific, not decided, moot, or simply boring).

  • Adverse events –